Atsushi Ogata1, Koichi Amano1, Hiroaki Dobashi1, Masayuki Inoo1, Tomonori Ishii1, Tsuyoshi Kasama1, Shinichi Kawai1, Atsushi Kawakami1, Tatsuya Koike1, Hisaaki Miyahara1, Toshiaki Miyamoto1, Yasuhiko Munakata1, Akira Murasawa1, Norihiro Nishimoto1, Noriyoshi Ogawa1, Tomohiro Ojima1, Hajime Sano1, Kenrin Shi1, Eisuke Shono1, Eiichi Suematsu1, Hiroki Takahashi1, Yoshiya Tanaka1, Hiroshi Tsukamoto1, Akira Nomura1. 1. From the Department of Respiratory Medicine, Allergy and Rheumatic Disease, Osaka University Graduate School of Medicine and Department of Immunopathology, WPI Immunology Frontier Research Center, Osaka University, Osaka; Department of Rheumatology and Clinical Immunology, Saitama Medical Center, Saitama Medical University, Saitama; Department of Internal Medicine, Division of Endocrinology and Metabolism, Hematology, Rheumatology and Respiratory Medicine, Faculty of Medicine, Kagawa University; Department of Rheumatology, Utazu-Hama Clinic, Kagawa; Department of Hematology and Rheumatology, Tohoku University Hospital, Sendai; Division of Rheumatology, Department of Medicine, Showa University School of Medicine; Division of Rheumatology, Department of Internal Medicine, Toho University School of Medicine, Tokyo; Unit of Translational Medicine, Department of Immunology and Rheumatology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki; Department of Rheumatosurgery, Osaka City University, Graduate School of Medicine, Osaka; Department of Internal Medicine and Rheumatology, National Hospital Organization Kyushu Medical Center, Fukuoka; Department of Rheumatology, Seirei Hamamatsu General Hospital, Shizuoka; Munakata Yasuhiko Clinic, Miyagi; Department of Rheumatology, Niigata Rheumatic Center, Niigata; Osaka Rheumatology Clinic, Osaka; Third Department of Internal Medicine, Hamamatsu University School of Medicine, Shizuoka; Department of Orthopedic Surgery, Fukui General Hospital, Fukui; Division of Rheumatology, Department of Internal Medicine, Hyogo College of Medicine, Hyogo; Department of Orthopedic Surgery, Osaka University Graduate School of Medicine, Osaka; Shono Rheumatology Clinic, Fukuoka; First Department of Internal Medicine, Sapporo Medical University School of Medicine, Hokkaido; The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Fukuoka; Department of Medicine and Biosy
Abstract
OBJECTIVE: To evaluate the longterm safety and efficacy of subcutaneous tocilizumab (TCZ-SC) as monotherapy in patients with rheumatoid arthritis (RA). METHODS: Of 346 patients who received 24 weeks of double-blind treatment with either TCZ-SC monotherapy, 162 mg every 2 weeks (q2w); or intravenous TCZ (TCZ-IV) monotherapy, 8 mg/kg every 4 weeks; 319 patients continued to receive TCZ-SC q2w in the 84-week open-label extension (OLE) of the MUSASHI study (JAPICCTI-101117). Efficacy, safety, and immunogenicity were evaluated for all patients treated with TCZ during 108 weeks. RESULTS: The proportions of patients who achieved American College of Rheumatology 20/50/70 responses, low disease activity [28-joint Disease Activity Score (DAS28) ≤ 3.2], or remission (DAS28 < 2.6) at Week 24 were maintained until Week 108. The incidences of adverse events and serious adverse events were 498.3 and 16.9 per 100 patient-years (PY), respectively. The overall safety of TCZ-SC monotherapy was similar to that of TCZ-IV monotherapy. Rates of injection site reactions (ISR) through 108 weeks remained similar to rates through 24 weeks. ISR were mild and did not cause any patient withdrawals. No serious hypersensitivity events (including anaphylactic reactions) occurred. Anti-TCZ antibodies were present in 2.1% of patients treated with TCZ-SC monotherapy. CONCLUSION:TCZ-SC monotherapy maintained a favorable safety profile and consistent efficacy throughout the 108-week study. Like TCZ-IV, TCZ-SC could provide an additional treatment option for patients with RA.
RCT Entities:
OBJECTIVE: To evaluate the longterm safety and efficacy of subcutaneous tocilizumab (TCZ-SC) as monotherapy in patients with rheumatoid arthritis (RA). METHODS: Of 346 patients who received 24 weeks of double-blind treatment with either TCZ-SC monotherapy, 162 mg every 2 weeks (q2w); or intravenous TCZ (TCZ-IV) monotherapy, 8 mg/kg every 4 weeks; 319 patients continued to receive TCZ-SC q2w in the 84-week open-label extension (OLE) of the MUSASHI study (JAPICCTI-101117). Efficacy, safety, and immunogenicity were evaluated for all patients treated with TCZ during 108 weeks. RESULTS: The proportions of patients who achieved American College of Rheumatology 20/50/70 responses, low disease activity [28-joint Disease Activity Score (DAS28) ≤ 3.2], or remission (DAS28 < 2.6) at Week 24 were maintained until Week 108. The incidences of adverse events and serious adverse events were 498.3 and 16.9 per 100 patient-years (PY), respectively. The overall safety of TCZ-SC monotherapy was similar to that of TCZ-IV monotherapy. Rates of injection site reactions (ISR) through 108 weeks remained similar to rates through 24 weeks. ISR were mild and did not cause any patient withdrawals. No serious hypersensitivity events (including anaphylactic reactions) occurred. Anti-TCZ antibodies were present in 2.1% of patients treated with TCZ-SC monotherapy. CONCLUSION:TCZ-SC monotherapy maintained a favorable safety profile and consistent efficacy throughout the 108-week study. Like TCZ-IV, TCZ-SC could provide an additional treatment option for patients with RA.
Authors: Alan Kivitz; Thomas Wallace; Ewa Olech; Michael Borofsky; Jenny Devenport; Jinglan Pei; Margaret Michalska Journal: Rheumatol Ther Date: 2016-09-24
Authors: Paul Emery; Janet E Pope; Klaus Kruger; Ralph Lippe; Ryan DeMasi; Sadiq Lula; Blerina Kola Journal: Adv Ther Date: 2018-08-20 Impact factor: 3.845
Authors: John D Isaacs; Abdelrazig Salih; Thomas Sheeran; Yusuf I Patel; Karen Douglas; Neil D McKay; Barbara Naisbett-Groet; Ernest Choy Journal: Rheumatol Adv Pract Date: 2019-04-19